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EC number: 206-059-0 | CAS number: 298-14-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards comparable to international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium hydrogencarbonate
- EC Number:
- 206-059-0
- EC Name:
- Potassium hydrogencarbonate
- Cas Number:
- 298-14-6
- Molecular formula:
- CH2O3.K
- IUPAC Name:
- potassium hydrogen carbonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 2.55 - 3.33 kg
- Housing: not reported
- Diet: ad libitum, Ssniff K, laboratory rabbit chow (Ssniff Versuchstier-Diäten GmbH, 4770 Soest/ Westfalen, Germany)
- Water: tap water, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): instilled undiluted in the original state as delivered by the sponsor - Duration of treatment / exposure:
- eyes were not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 male rabbits
- Details on study design:
- The animals were treated with 0.1 ml of the test article, which was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one to two seconds, afterwards animals were returned to their cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
- as stipulated by Draize 1959 and guideline for acute eye irritation of US Interagency Regulatory Liaison Group (IRLG) Testing Standards and Guidelines Work Group (January 1981)
READINGS:
- 1 hour, 1, 2, 3, 4 and 7 days after instillation of test substance
TOOL USED TO ASSESS SCORE:
- 24 hours before treatment eyes were examined for lesions after application of fluorescein 0.15 %.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 day in one animal
- Remarks on result:
- other: no observation beyond 7 days, clear tendency to reversibility from day 4 onward
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 day in one animal
- Remarks on result:
- other: no observation beyond 7 days, clear tendency to reversibility from day 3 onward
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #3, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- No effects on iris were observed. 1/6 animals showed a transient corneal opacity score 1 one hour after substance application. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at the first scoring one hour after substance instillation (conjuncival redness score 1 in 2/6 and score 2 in 4/6 animals, chemosis score 2 score in 5/6 and score 3 in 1/6 animals, discharge score 1 in 5/6 and score 2 in 1/6 animals). A tendency to reversibility was seen from scoring at day 1 onward. All animals were free of corneal opacity one day after treatment. Conjunctival redness was fully reversible in 4/6 animals and almost reversible in the remaining 2/6 animals within the observation period of 7 days. Chemosis and discharge were fully reversible in all animals at day 4.
Any other information on results incl. tables
rritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
|
Max. score: 4 |
Area affected |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max.score: 3 |
|
1 hour |
1/0/0/0/0/0 |
4/0/0/0/0/0 |
0/0/0/0/0/0 |
2/2/2/2/1/1 |
2/3/2/2/2/2 |
1/1/1/1/1/2 |
Day 1 (24 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/2/2/1/2 |
1/2/1/1/2/2 |
0/1/1/0/1/1 |
Day 2 (48 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/2/2/1/2 |
0/2/1/0/2/1 |
0/1/1/0/1/1 |
Day 3 (72 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/2/1/1/1/2 |
0/2/1/0/0/0 |
0/0/1/0/0/0 |
Day 4 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/1/1/1/1 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Day 7 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/1/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0.67/2/1.67/1.67/1/2 |
0.33/2/1/0.33/1.33/1 |
0/0.67/1/0/0.67/0.67 |
Reversibility # |
c |
c |
n* |
c |
c |
# Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible
* The observation time did not extend beyond 7 days, even through slight eye responses were still present at that time, therefore, the reversibility of the eye effects cannot be proved. However, ocular lesions showed a clear tendency of reversibility. At study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Therefore, a full reversibility in all animals is very likely if the observation period would have been extended to 21days, as required according to recent guidelines.
Mean Total Scores (MTS) according to Kay and Calandra were calculated and used for classification by the study authors:
1h: MTS = 13.3
1d: MTS = 7.7
2d: MTS = 6.7
3d: MTS = 3.7
4d: MTS = 1.7
7d: MTS = 0.7
Maximum Mean Total Score (MMTS) possible: 110)
Based on these mean scores, according to the classification scheme of Kay and Calandra the test item was considered to be mild irritating (class 4 of maximum possible 8) by the study authors.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Judgment is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
Test substance induced neither substantial corneal opacity nor iritis. Mean values of eye response at 24, 48 and 72 h for conjunctival redness and chemosis were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008 and reversibility of effects can be assumed. Therefore, no classification for serious eye damage/eye irritation is justified for test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) according to Regulation (EC) No 1272/2008. - Executive summary:
In a primary eye irritation study according to FDA (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), 0.1 ml of test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) was instilled into the conjunctival sac of 6 male New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize. No effects on iris were observed. 1/6 animals showed a transient corneal opacity score 1 one hour after substance application. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at the first scoring one hour after substance instillation (conjuncival redness score 1 in 2/6 and score 2 in 4/6 animals, chemosis score 2 score in 5/6 and score 3 in 1/6 animals, discharge score 1 in 5/6 and score 2 in 1/6 animals). A tendency to reversibility was seen from scoring at day 1 onward. All animals were free of corneal opacity one day after treatment. Conjunctival redness was fully reversible in 4/6 animals and almost reversible in the remaining 2/6 animals within the observation period of 7 days. Chemosis and discharge were fully reversible in all animals at day 4. The observation time did not extend beyond 7 days, even through slight eye responses were still present at that time. Sinve, ocular lesions showed a clear tendency of reversibility, there are no indications that these effects would not be reversible after 21 days. At study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Therefore, a full reversibility in all animals is very likely if the observation period would have been extended to 21days, as required according to recent guidelines. Test substance induced neither substantial corneal opacity nor iritis. Mean values of eye response at 24, 48 and 72 h for conjunctival redness and chemosis were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008. Study was terminated at study day 7 before ocular lesions fully reversed in all animals. However, fully reversibility can be assumed. Therefore, the test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) was considered not irritating.
According to the eye irritation/corrosion test guidelines EU Method B.5 and OECD TG 405 stipulated in COUNCIL REGULATION (EC) No 440/2008, observation to full reversibility or 21 days is claimed. This is not fulfilled by this study, since study was terminated before eye effects completely reversed in all animals.However, complete reversibility can be assumed from healing process.
No classification for serious eye damage/eye irritation is justified for "Kaliumbikarbonat" (potassium hydrogencarbonate) according to the following regulations:
- CLP - (EU-GHS), Regulation (EC) No 1272/2008
- OECD GHS, (2nd rev. edition, UN, 2007)
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